Model Number S7 |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.It was reported that the surgeon monitor for the navigation system was replaced to resolve the issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The monitor for the navigation system was returned to the manufacturer for analysis.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.
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Event Description
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A medtronic representative reported that, while in a cranial resection, the surgeon monitor of the navigation system was "flickering" and that the monitor would intermittently lose functionality.A second monitor was used to complete the procedure.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.No additional information was provided.
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Manufacturer Narrative
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Correction: device manufacture date updated to proper value.
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Search Alerts/Recalls
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